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FDA‌ Drugs Registration Assistance

FDA OTC Drug Establishment Registration and OTC Drug Listing

Navigate the OTC Drug Registration Steps - from establishment registration to obtaining labeler code and OTC drug listing- and learn how to bring OTC products to the U.S. market.

FDA Drug Labeling and Ingredient Requirement

Ensure FDA compliance for your OTC drug labeling with FDA Listing Inc. Our experts analyze your label, provide comprehensive reviews, and suggest proper formats for packaging. Request a free initial assessment now!

FDA National Drug Code NDC Labeler Code

Obtain the National Drug Code (NDC) Labeler code for your drug products by submitting a request in SPL format. FDA Listing Inc. can assist you as a U.S. agent in preparing and submitting the necessary files.

FDA Drug Establishment Registration and FDA Drug Listing

Simplify FDA drug establishment registration and listing. FDA Listing Inc. serves as your U.S. Agent and assists with the Electronic Drug Registration and Listing System (eDRLS). Ensure compliance and register your products with ease.

FDA Drug Color Additives Requirement

All drug color additives must be FDA approved for their specific intended use and formulation. Drug colors additives must be either FDA certified colors (on a batch basis), or exempted from FDA color certification. Batch Certification is a process by which FDA evaluates the composition of all colors used in drug formulation. To obtain the color additive batch certification, drug manufacturers must submit a sample of the color additive for each batch used in the product formulation along with the batch-specific documents. After proper examinations U.S. FDA will certify the color additive if the analysis of the batch sample meets the FDA requirements.

Continue Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.

U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info